DEC-NET Serial number GB297 | | Published online | 22/07/2004 17.29.00 | Last updated | 09/08/2005 11.40.02 | | | | | This trial has been approved by an ethics committee |
Current trial status | Complete(closed to recruitment of participants: follow-up complete) |
Target N. of subjects
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30
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Major Disease (ICD9 class) | DWARFISM NOT ELSEWHERE CLASSIFIED | Experimental drug |
Somatropin
Treatment regimen (dosage and duration) 20 versus 40 Units per metre square body surface area per week |
Gender | Both | Age (range) | < 10 years | Eligibility criteria | Inclusion criteria | Normal growth hormone secretion | Exclusion criteria | Growth hormone deficiency or skeletal dysplasia | Trial design/methodology | Phase | 4 | Kind of study | Efficacy Safety
| Design | Controlled Blinded Single blind
| Purpose of study | What cardiovascular effects are seen in children of short stature treated with biosynthetic growth hormone? | Primary outcomes | Final Height | Secondary outcomes | Cardiac Function | Summary of study design, objectives, and ongoing research findings | Clinical Trial without Randomisation.
What cardiovascular effects are seen in children of short stature treated with biosynthetic growth hormone?
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Principal investigator | Name | Dr PC Hindmarsh | Institution | Cobbold Laboratories, The Middlesex Hospital | Postal address | Department of Paediatrics, Cobbold Laboratories, 7th Floor, The Middlesex Hospital, Mortimer Street, London, W1N 8AA | City | London | Country | UNITED KINGDOM | Phone | 020 7380 9450 | Fax | 020 7636 9941 | E-mail | p.hindmarsh@ucl.ac.uk |
Sponsor name | Children Nationwide Research Fund (Charity) |
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